Erbe Medical recalls CleverCap CO2 tubing/cap sets for Olympus and other scopes due to potential water aspiration leading to pneumonia or respiratory failure. Affected units include specific model numbers and production lots.
Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.
Erbe Medical is recalling CleverCap CO2 tubing/cap sets for Olympus and other endoscopes because a design flaw may cause water to flow into the patient's lungs during use, potentially leading to pneumonia or respiratory failure. This is serious enough to require immediate action to prevent health risks.
The tubing's distal connector may allow water to flow from the endoscope tip when used with third-party connectors that aren't properly supported. This can lead to water entering the patient's lungs, causing aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.
Endoscopists and medical professionals who use the recalled CleverCap CO2 tubing/cap sets for Olympus and other scopes are most at risk. Patients undergoing procedures with these devices could face aspiration pneumonia or respiratory failure.
Check for model numbers 20325-239, 20325-240, 20325-206, 20325-207, 20325-248, or 20325-208 on the product. The recall includes specific production lots and serial numbers listed in the official notice.
Discontinue use of the recalled CleverCap CO2 tubing/cap sets as they pose a risk of water aspiration leading to serious health complications.
The affected models include 20325-239, 20325-240, 20325-206, 20325-207, 20325-248, and 20325-208.
Check the model number on your product and compare it to the list of affected numbers provided in the recall notice, including specific production lots and serial numbers.
Immediately stop using the product and contact Erbe Medical for further instructions.
We’ve drafted a message you can send Erbe Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2062-2026 — Erbe Medical Erbe Medical Hello, I own a Erbe Medical that is covered by recall Z-2062-2026 from Erbe Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
